Paul Gilman Plenary Message to WTQA Symposium

August 12, 2002

As the Agency’s new Science Advisor as well as the Assistant Administrator for Research and Development, it is a pleasure to address a group that is in the forefront of environmental monitoring science. The work that you and your colleagues perform is critical to solving our nation’s environmental problems. Without quality data, those of us in federal and state government service who are charged with determining our nation’s environmental policies will have an extremely difficult time selecting the correct courses of action. In my message to you, I want to share some of my thoughts and objectives in two areas. These are: (1) accreditation of environmental laboratories and (2) Agency efforts to strengthen science in the environmental arena.

Laboratory Accreditation

EPA is very supportive of the efforts being made to establish a national environmental laboratory accreditation system. I believe that its implementation will have a number of very positive benefits. These benefits include:

Improving the level of staff expertise in the environmental laboratories as a result of having established minimum education, training, and experience standards for laboratory management and staff;

Ensuring that laboratories have suitable quality systems and that the systems are operating;

Reducing the costs of accreditation to the laboratory industry and to the state accreditation programs;

Bringing a degree of consistency and quality to state accreditation programs;

Helping to eliminate the problem of incompetent laboratories; and

Assisting purchasers of laboratory services in finding competent laboratories to do their work.

For these benefits to accrue, however, it is critical that we have a truly national program where accreditations by any member accrediting authority are recognized by all states, the federal government and the tribes.

In this regard, EPA has, and will continue to actively support the National Environmental Laboratory Accreditation Conference (NELAC) effort to establish a national system through both staff participation, and by providing a degree of financial support. In addition, as the Agency’s Science Advisor, I will do all I can to generate support across EPA for the program and at senior levels in the states.

However, while the Agency is supportive of the NELAC efforts, EPA would like to see a number of changes made in the program. EPA does not believe that laboratory accreditation is an inherently governmental function. In fact, I believe that the national accreditation system should not be government run. Standards should be developed by groups representing and including all sectors of the environmental community. Here I include, the federal government, the states, the commercial and in-house laboratories, the engineering firms who are major users of data generated by the laboratories, as well as all the other parties who are the purchasers or users of laboratory services and data. In this regard, EPA was very pleased to see that the NELAC community adopted a new structure at their recent annual meeting. Under the new structure, accreditation standards will, henceforth, be developed by national consensus standards developing bodies where experts from all sectors of the monitoring community can work together, as equals, to develop the accreditation standards.

I also strongly believe that we still need to look at what mechanism should be used to approve the laboratory accreditation standards; what organization(s) should perform the laboratory auditing function and ensure the competency of the auditors; who should accredit the laboratories; and how to ensure that US accreditation standards comport with international standards in order that US environmental testing laboratory accreditations are recognized by other nations. I hope that the NELAC community will continue to look at these issues between now and its next annual meeting.

One area where I feel the NELAC program needs to be strengthened is with regard to the personnel performing the laboratory audits. Laboratory auditing needs to be performed by persons who are experienced in laboratory operations. It is critically important that the auditors really understand how laboratory operations are performed and how laboratories operate if they are to effectively identify operations that do not meet the accreditation standards. In addition, auditors can and often do help laboratories improve their operations by identifying areas where improvement is needed and by recommending appropriate courses of action. Such services can only be performed by competent, knowledgeable auditors.

One aspect of a national environmental laboratory accreditation program that I want to take a moment and focus on concerns funding. How to make such a program financially secure. EPA believes that the accreditation program should be self sufficient and its funding sources broad based. Examples of funding sources that should be looked at include: membership dues from accrediting authorities; contributions from organizations such as EPA and other large users of laboratory services; and fees charged to laboratories for accreditation.

Finally, I want to reiterate the need for NELAC to adopt a system that focuses on the laboratory needs to meet project-specific, customer-established data quality objectives (the ISO 17025 or Performance Approach) rather than to continue with the required-method approach. As part of this change, the accreditation community needs to take a new look at its approach to “fields of accreditation” since the current methods based approach acts as a roadblock to implementing the performance approach. Now that EPA is finally beginning to implement the performance-based measurement system and build flexibility into its measurement requirements, this is a critically important change that needs to be made.

Agency Efforts to Strengthen Science

This past April, EPA Administrator Christie Whitman announced that, in order to strengthen the role of science at the Agency, she was creating the position of Science Advisor and was appointing me to that position. As her Science Advisor, I am responsible for working with all parts of the Agency to ensure that high quality science is fully integrated into the Agency's programs, policies and decisions.

This afternoon, I would like to take a few moments and discuss some areas within the environmental monitoring arena, that I plan to focus on in order to ensure that the Agency’s decisions are supported by the best available science.

I will increase Agency efforts to implement the performance approach by working with senior management of our Program Offices and Regions to modify the regulations and permitting procedures to not only allow but to encourage use of new measurement technologies. While progress has been made in regard to implementing the performance approach, as you will hear about in a few minutes from my colleague Elizabeth Cotsworth, more needs to be done and I will work to speed up the pace of implementation.

One reason that mistakes are sometimes made when conducting monitoring or data gathering programs is that the people conducting the studies do not always spend enough time to properly plan the work. We need to ensure that all measurements are made under a “plan” that describes the question(s) to be answered and either the required accuracy of the data, or the minimum degree of certainty with regard to the answer to the questions. We need to require that the actual quality of all our data be documented. While current Agency policy requires that before any testing is performed a Quality Assurance Project Plan has to be prepared and approved by the Quality Assurance Officer (QAO), this process needs to be strengthen and the states and the private sector need to be encouraged to adopt a similar approach. If quality assurance project plans were properly prepared and followed, three benefits would ensue.

(1) The appropriateness of all the methodology that is used to collect the data would be assured.

(2) The defensibility of the data that the Agency uses in its decision making would be strengthened, since the actual quality of the data would be documented.

(3) Management will be more confident of its decisions since we will know the statistical quality of the data and results.

In a number of instances, the Agency has been criticized that the methods that we issue do not always perform as advertised. I believe that for the most part, the criticism is not warranted. However, in order to ensure that all EPA methods can actually achieve the performance that is advertised, I will work to require outside peer review of all new measurement methods issued by the Agency. Such reviews would not be under control of issuing/developing organization - whether it be my own Office of Research and Development, a Program Office, or any other EPA organization. As you know, EPA policy is to not issue monitoring requirements unless methodology exists that the regulated community can use to meet the monitoring requirements. By employing outside peer review, I hope that we can eliminate any future situations where EPA-issued or EPA-cited methods do not provide the degree of accuracy or sensitivity that you need to meet Agency monitoring requirements.

The Agency has been working to strengthen its internal procedures to improve its data gathering and information product generation procedures. The effort is termed the Data Quality Strategic Plan and, it is my understanding, that you were briefed on this effort at this symposium last year. A number of components of the strategy only affect how EPA conducts it internal activities. However, one aspect of the strategy, that may impact you and that I would like to see the Agency implement as quickly as possible, will be to require that the quality of all data generated by, or generated for, the Agency be actually determined and documented. While this would be a significant change in how we do business, this move mirrors the efforts being made by NELAC, ASTM and ISO.

As some of you may be aware of and have already been following, in 1999, Congress mandated that each federal agency develop and issue guidelines to improve the quality of the information that the Agency generates, uses, and disseminates. Under guidance issued by the Office of Management and Budget, EPA is now developing its implementation guidelines which are to be issued by October 1, 2002. Our guidelines build upon numerous established agency policies and procedures for ensuring the quality of information. While you will hear more details about this effort later in the Conference, I want to highlight two areas that we are working on.

First, while the Agency will continue to do its utmost to ensure that the information that we use and disseminate is of high quality, sometimes bad information slips through. As a result of our continuing commitment to take timely action to correct such errors, the Agency will modify its information correction process to make it easier for you to get errors in Agency information corrected.

Second, since the bulk of the Agency data comes from outside sources, EPA is developing a series of assessment factors that the Agency will publish and use to evaluate the credibility and appropriateness of data and information obtained from outside sources. The goal is to minimize the possibility of EPA receiving and using data and information that is not suitable for the use to which it is being put.

As you know, it is often very difficult for someone outside the Agency, and sometimes even for someone inside the Agency, to find appropriate measurement methods that have been developed or issued by the Agency. ORD, each of our Program Offices, the Regions, all develop and publish measurement methods. Some of the methods are available on the Agency’s web site but many are not. In addition, navigating the various Agency web sites and finding a particular method is very difficult. The web sites also do not make it easy to determine which of the many seemingly identical methods is appropriate for a particular application. I know that our Region 1 library has, for several years, been issuing an index to EPA’s various testing methods. I do not know if this index is complete, but it has helped serve as a roadmap. Also, I understand that the National Water Quality Advisory Board is in the process of developing a comprehensive index to environmental monitoring methods issued by EPA, other federal agencies and national and international standards setting bodies. Their effort is called the National Environmental Methods Index and it looks like it will be a very valuable tool. However, this still leaves the problem of obtaining the cited methods once you have identified which ones are appropriate for your application. As Science Advisor, I will discuss with other Agency senior managers the possibility of establishing a centralized web-based registry of analytical and other measurement methods that cuts across programs/ORD/regions. Having a central location on the EPA web site for all Agency methods would be a tremendous service to the public [and to EPA’s own staff] and also, hopefully, cut down on unnecessary duplication of effort with regard to methods publication. Such a registry would make it much easier for you to obtain methods that are cited in regulations, guidance, and the previously mentioned indicies.

Earlier I spoke of my commitment to helping to establish a national accreditation program for environmental laboratories. As the Science Advisor, one of my goals is to promote the acceptance by senior Agency and State management of the program and the use of accreditation as a means of improving the quality of our nation’s environmental testing laboratories. As I mentioned earlier, laboratory accreditation provides a means of ensuring that laboratories are competent to perform the type of tests that they have been accredited to perform. By actively promoting the concept of only using quality laboratories, I hope that the Agency can do its part to eliminate, or at least reduce, the credibility problems facing the environmental laboratory community. I would like to take this opportunity to solicit your ideas and suggestions as to what specific changes can and should be made in the procurement process to ensure that the Agency only contracts with competent laboratories.

Thank you for giving me the opportunity to share some of my ideas and priorities with you. You are a key to quality science. The quality of the data and information that you supply largely determines how well we do our job and how well we can determine whether our efforts are succeeding.